Evaluation of the Effects of Local Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) in Adjuvant Administration on Dendritic Cells in Skin of Melanoma Patients and in Sentinel Lymph Nodes: MEL38

Inclusion Criteria:

Patients who have been diagnosed, by histologic and clinical examination, with resected AJCC stage I or II melanoma.
Patients who have any evidence of metastasis will not be eligible.

All patients must have:

Karnofsky performance of 80% or higher
ECOG performance status of 0 or 1
Ability and willingness to give informed consent

Laboratory parameters as follows:

ANC: 90% of lower limit of normal (LLN) to 120% of upper limit of normal (ULN)
Platelets: 100-500 x 103/uL
Hgb: 90% LLN to 120% ULN

Hepatic:

AST, ALT, Bilirubin, and Alk phos within normal limits,
LDH up to 1.2 x ULN

Renal:

Creatinine up to 1.5 x ULN
Age 18-85 years at the time of study entry.

Exclusion Criteria:

Patients who are currently receiving cytotoxic chemotherapy, interferon, or radiation or who have received this therapy within the preceding 12 weeks.
Patients with known or suspected allergies to any component of the vaccine.

Patients receiving the following medications at study entry or within the preceding 4 weeks are excluded:

Agents with putative immunomodulating activity (with the exception of non-steroidal anti-inflammatory agents),
Allergy desensitization injections,
Corticosteroids, administered parenterally or orally. Topical corticosteroids are acceptable.
Any growth factors, Interleukin-2 or other interleukins.
Pregnancy or the possibility of becoming pregnant during vaccine administration. Female patients of child-bearing potential must have a negative pregnancy test (urinary or serum beta-HCG) prior to administration of the injection.
Patients in whom there is a medical contraindication or potential problem in complying with the requirements of the protocol, in the opinion of the investigator.
Patients classified according to the New York Heart Association classification as having Class III or IV heart disease.
Patients with serious symptomatic active pulmonary disease, with pleural effusions, or with a history of pulmonary edema.
Patients who have systemic autoimmune disease with visceral involvement.
Patients with clinically apparent skin infection or other clinically evident inflammation involving the skin adjacent to the melanoma biopsy scar.